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Trial registered on ANZCTR


Registration number
ACTRN12610000995077
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
16/11/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate Graftys(R)HBS or Graftys(R)QUICKSET for the Treatment of Unstable Distal Radius Fractures
Scientific title
A Prospective, Randomized, Controlled, Pilot Clinical Study to Evaluate Graftys(R)HBS or Graftys(R)QUICKSET for the Treatment of Unstable Distal Radius Fractures
Secondary ID [1] 252983 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractures of the Distal Radius 258523 0
Condition category
Condition code
Injuries and Accidents 258679 258679 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study device, Graftys(R)HBS or Graftys(R)Quickset, is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute.
Both of them demonstrate approximately 65-70% total porosity, of which about 8% is macroporosity (pore size from 100 to 300 microns).
Graftys(R)HBS is a low viscosity cement that has a longer setting time and a lower compressive strength but which can be applied through a narrow gauge cannula. Graftys(R)Quickset has a highly viscosity and shorter setting time
This is a prospective, randomised, controlled pilot study to evaluate the safety and clinical utility (i.e., performance, functional radiographic parameters) of Graftys(R)HBS or Graftys(R)Quickset in the treatment of unstable distal radius fractures. All enrolled subjects will be treated by percutaneous reduction, minimally invasive or noninvasive fixation techniques, including casting, external fixation, external fixation with percutaneous pins, percutaneous pins or screws with cast or percutaneous pins with cast. The resulting bone void will be grafted with Graftys(R)HBS (Arm 1), Graftys(R)Quickset (Arm 2) or no bone void filler (Arm 3), when assigned by the randomization schema.
The graft material will be implanted percutaneously or manually packed into the fracture space, dependent upon the method of fixation, prior to, during, or following reduction and fixation and stabilisation of the fracture.
The graft material will be constructed to fill comminuted fracture spaces via interdigitation within comminuted cancellous bone, both dorsally, distally and proximally. The degree of fill required may vary from less than 2mm to as much as 2cm depending on the amount of bone involved.
When implanted, the graft material may prevent the collapse of a fracture caused by compressive forces generated by the muscle tendon units crossing the fracture site. The procedure time will vary depending on time taken to achieve an adequate reduction of the fracture.
Intervention code [1] 257504 0
Treatment: Devices
Intervention code [2] 257606 0
Treatment: Surgery
Comparator / control treatment
Fixation of distal radius fractures with kirschner (K)-wire fixation without supplemental bone grafting.
Control group
Active

Outcomes
Primary outcome [1] 259536 0
The primary objective is to maintain position reduction as per X-ray/CT scan analysis.
The hypothesis for this study is that Graftys(R)HBS or Graftys(R)Quickset, when applied to the bone void, will result in accelerated time to fracture healing, as measured functionally, clinically, and/or radiographically.
Timepoint [1] 259536 0
Subjects will be evaluated via X-ray at 1 week, 2 weeks, 6 weeks, 3 months and 6 months. CT scans will be performed at 1 week and 6 months.
Secondary outcome [1] 266151 0
Evaluate the patient's physical function (such as Grip strength, Range of Motion and Hand Function) utilising the Disabilities of the Arm, Shoulder and Hand (DASH). The DASH measures physical function and symptoms in people with musculoskeletal disorders of the upper limb.
Timepoint [1] 266151 0
Subjects will be evaluated at 6 weeks, 3 months and 6 months.

Eligibility
Key inclusion criteria
1. Patient has signed the FCREC approved Informed Consent Form specific to this study prior to enrollment, and are willing to participate in the length of the study including prescribed follow-ups.

2. The patient has an unstable, unilateral, extra-articular distal radius fracture which is widely displaced with extensive dorsal comminution, dorsal angulation greater than 20 degrees. Avulsed ulnar styloid tip is allowed.

3. Patient’s fracture is able to be manually reduced in a single attempt up to 2 weeks post injury.

4. Patient is independent, ambulatory, and can comply with all post-treatment
evaluations and visits.

5. Patient is skeletally mature and =18 years of age.

6. The distal radius fracture does not require structural bone graft.

7. Patient has Colles fracture (extra-articular fracture)
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has suffered a previous wrist fracture on the affected wrist or contralateral wrist within the previous 12 months of the current fracture date.

2. Patient’s fracture meets any of the following criteria:
Bilateral distal radius fractures or clinically significant injury to the contralateral limb.
Severe comminution involving the diaphysis of the radius and/or radioulnar joint.
Ulnar fracture (AO: A1.1, A1.2, and A1.3)/Ulnar styloid.
Presence of pre-operative hard or soft tissue infection at the operative site.
Requires supplemental internal fixation for adequate reduction (e.g. plates)
Open fractures
Closed head injuries
Intra-articular fracture with diastasis of the subchondral bone.

3. Patient is currently undergoing radiotherapy or chemotherapy.

4. Patient has a metabolic disorder known to adversely affect the skeleton, other than primary osteoporosis (e.g., renal osteodystrophy)

5. Patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Note: NSAID use is excluded during the first 6 weeks post-treatment.

6. Patient has a clotting disorder or uses anticoagulant therapy (e.g., coumadin). Antiplatelet therapy is acceptable for daily cardiovascular maintenance.

7. Patient has a Smith fracture.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting in the trauma clinic with a distal radius fracture will be evaluated and considered for study participation by the participating investigator/delegate. Patients will be selected according to the inclusion/exclusion criteria. Enrollment in the study begins at the time written consent is obtained. The Investigator or designee is responsible for verifying that the subject meets all inclusion and has none of the exclusion criteria prior to randomisation of the subject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each center, the subjects will be randomly assigned to one of the following groups in a 1:1:1 block randomisation: Group I: Graftys(R)HBS;
Group II Graftys(R)Quickset;
Group III: No bone graft material.
Randomization assignments will not be re-used in the event that the subject withdraws from the study prior to treatment, or becomes an intra-operative treatment failure. It is suggested that randomization occur within 48 hours of the scheduled surgery.


There are equal numbers of patients in each group, ie (Minimum of 10 to a maximum of 50 patients per study arm)

A 1:1:1 block randomisation will be used in the study. The assignments are predetermined through a schedule generated using randomly permuted blocks with random block sizes method. Randomisation plan generator available on the randomisation.com website was used (Dallal, 2008)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257955 0
Commercial sector/Industry
Name [1] 257955 0
Austofix
Country [1] 257955 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Austofix
Address
18 Kinkaid Ave
North Plympton, SA, 5037
Country
Australia
Secondary sponsor category [1] 257155 0
None
Name [1] 257155 0
Address [1] 257155 0
Country [1] 257155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259964 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 259964 0
Southern Adelaide Health Service SA Health
Flinders Medical Centre
Flinders Drive, Bedford Pk, 5042,
South Australia
Ethics committee country [1] 259964 0
Australia
Date submitted for ethics approval [1] 259964 0
Approval date [1] 259964 0
14/10/2010
Ethics approval number [1] 259964 0

Summary
Brief summary
This is a prospective, randomised, controlled pilot study to evaluate the safety and clinical utility (i.e., performance, functional radiographic parameters) of Graftys(R)HBS or Graftys(R)Quickset in the treatment of unstable distal radius fractures, when used with fractures treated by Kirschner wire fixation. The study will enroll a minimum of 10 patients to a maximum of 50 patients per arm requiring treatment of a primary unstable distal radius fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31847 0
Address 31847 0
Country 31847 0
Phone 31847 0
Fax 31847 0
Email 31847 0
Contact person for public queries
Name 15094 0
Mr David Brammy
Address 15094 0
18 Kinkaid Ave
North Plympton, SA, 5037
Country 15094 0
Australia
Phone 15094 0
+61 883510644
Fax 15094 0
+61 883510855
Email 15094 0
[email protected]
Contact person for scientific queries
Name 6022 0
Mr David Brammy
Address 6022 0
18 Kinkaid Ave
North Plympton, SA, 5037
Country 6022 0
Australia
Phone 6022 0
+61 883510644
Fax 6022 0
+61 883510855
Email 6022 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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